Neo-Tee T-Piece Resuscitator — Class I medical device recall Z-0821-2025
Ongoing recall by Mercury Enterprises, Inc. dba Mercury Medical, reported 2025-01-22, distributed nationwide. Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which
| Recall number | Z-0821-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mercury Enterprises, Inc. dba Mercury Medical, Clearwater, FL, United States |
| Recall initiated | 2024-12-10 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CH, ES, FR, GB, HK, HU, IT, NL, SA |
| Quantity | 37,370 |
| UPC / GTIN / UDI-DI | 10641043508053, 10641043508084, 10641043508091, 10641043508107, 10641043508114, 10641043508145, 10641043508329, 10641043508398, 10641043508404, 10641043508411, 10641043508428, 30641043508057, 30641043508088, 30641043508095, 30641043508101, 30641043508118, 30641043508149, 30641043508323, 30641043508392, 30641043508408, 30641043508415, 30641043508422 |
| Lot numbers | 1050805/10641043508053, 1050808/10641043508084, 1050809/10641043508091, 1050810, 1050811/10641043508114, 1050814/10641043508145, 1050832/10641043508329, 1050839/10641043508398, 1050840/10641043508404, 1050841/10641043508411, 1050842/10641043508428, 2423550805, 2423650805, 2426650811, 2426750805, 2426750808, 2426750809, 2426750811, 2426750814, 2426850808, 2429050808, 2429050809, 2429050811, 2429050814, 2429150809, 2429150811, 2429250811, 2429350808, 2429350809, 2429350810, 2429350811, 2429450811, 2429750809, 2429750810, 2429750811, 2429750814, 2429750840, 2429850809, 2429850810, 2429850811 and 18 more |
| Model numbers | 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842 |
Product
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Reason for recall
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0821-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.